Occlusive cinching devices and methods of use

ABSTRACT

Methods and devices for blocking orifices and occluding cavities within a patient are provided. The device in one variation comprises first and second tubular members attached to a collapsible sealing element. The device can be placed through an orifice and the collapsible sealing element can be collapsed to seal the orifice. An embolic may be introduced distal to the sealing element to occlude a cavity. The device may incorporate a locking mechanism which can be engaged to lock the sealing element into the collapsed position. The device may incorporate a valve to prevent flow through the tubular members, for example to prevent egress of the embolic from a cavity. The device can be detached to provide a permanent seal of the orifice, and can retain the embolic within the cavity. The device may be used in conjunction with a stent or other retention device to assist the sealing element in maintaining the seal.

RELATED APPLICATION DATA

The present application is a continuation of U.S. application Ser. No.13/013,044, filed Jan. 25, 2011, which is a continuation of U.S.application Ser. No. 11/748,221, filed May 14, 2007, which is acontinuation of U.S. application Ser. No. 10/338,514, filed Jan. 7,2003, now U.S. Pat. No. 7,229,454, the priority of which is claimedunder 35 U.S.C. .sctn.120, and the contents of which are incorporatedherein by reference in their entirety, as though set forth in full.

TECHNICAL FIELD

This invention relates to methods and devices for blocking orifices andoccluding cavities within a patient.

BACKGROUND OF THE INVENTION

The present invention deals with a system for treating an aneurysm. Morespecifically, the present invention deals with a removable occlusionsystem deployed in the vasculature containing the aneurysm.

Several methods of treating aneurysms have been attempted, with varyingdegrees of success. For example, open craniotomy is a procedure by whichan aneurysm is located, and treated, extravascularly. This type ofprocedure has significant disadvantages. For example, the patientundergoing open craniotomy must undergo general anesthesia. Also, thepatient undergoes a great deal of trauma in the area of the aneurysm byvirtue of the fact that the surgeon must sever various tissues in orderto reach the aneurysm. In treating cerebral aneurysms extravascularly,for instances, the surgeon must typically remove a portion of thepatient's skull, and must also traumatize brain tissue in order to reachthe aneurysm.

Other techniques used in treating aneurysms are performedendovascularly. Such techniques typically involve attempting to form amass within the sac of the aneurysm. Typically, a microcatheter is usedto access the aneurysm. The distal tip of the micro catheter is placedwithin the sac of the aneurysm, and the microcatheter is used to injectembolic material into the sac of the aneurysm. The embolic materialincludes, for example, detachable coils or an embolic agent, such as aliquid polymer. The injection of these types of embolic materials sufferfrom disadvantages, most of which are associated with migration of theembolic material out of the aneurysm into the parent artery. This cancause permanent and irreversible occlusion of the parent artery.

For example, when detachable coils are used to occlude an aneurysm whichdoes not have a well defined neck region, the detachable coils canmigrate out of the sac of the aneurysm and into the parent artery.Further, it is, at times, difficult to gauge exactly how full the sac ofthe aneurysm is when detachable coils are being injected. Therefore,there is a risk of overfilling the aneurysm in which case the detachablecoils also spill out into the parent artery.

Another disadvantage of detachable coils involves coil compaction overtime. After filling the aneurysm, there remains space between the coils.Continued hemodynamic forces from the circulation act to compact thecoil mass resulting in a cavity in the aneurysm neck. Thus, the aneurysmcan recanalize.

Embolic agent migration is also a problem. For instance, where a liquidpolymer is injected into the sac of the aneurysm, it can migrate out ofthe sac of the aneurysm due to the hemodynamics of the system. This canalso lead to irreversible occlusion of the parent vessel.

Techniques have been attempted in order to deal with the disadvantagesassociated with embolic material migration to the parent vessel. Somesuch techniques, commonly referred to as flow arrest techniques,typically involve temporarily occluding the parent vessel proximal ofthe aneurysm, so that no blood flow occurs through the parent vessel,until a thrombotic mass has formed in the sac of the aneurysm whichhelps reduce the tendency of the embolic material to migrate out of theaneurysm sac. However, thrombotic mass can dissolve through normal lysisof blood. Also, in certain cases, it is highly undesirable to occludethe parent vessel even temporarily. Therefore, this technique is, attimes, not available as a treatment option. In addition, even occludingthe parent vessel may not prevent all embolic material migration intothe parent vessel.

Another endovascular technique for treating aneurysms involves insertinga detachable balloon into the sac of the aneurysm using a microcatheter.The detachable balloon is then inflated using saline and/or contrastfluid. The balloon is then detached from the microcatheter and leftwithin the sac of the aneurysm in an attempt to fill the sac of theaneurysm. However, detachable balloons also suffer disadvantages. Forexample, detachable balloons, when inflated, typically will not conformto the interior configuration of the aneurysm sac. Instead, thedetachable balloon requires the aneurysm sac to conform to the exteriorsurface of the detachable balloon. Thus, there is an increased risk thatthe detachable balloon will rupture the sac of the aneurysm. Further,detachable balloons can rupture and migrate out of the aneurysm.

SUMMARY OF THE INVENTION

Methods and devices for blocking orifices and occluding cavities withina patient are provided. The device comprises first and second tubularmembers attached at their distal ends to a collapsible sealing element.The device can be placed through an orifice and the collapsible sealingelement can be collapsed to seal the orifice. An embolic may beintroduced distal to the sealing element to occlude a cavity. The devicemay incorporate a locking mechanism which can be engaged to lock thesealing element into the collapsed position. The device may incorporatea valve to prevent flow through the tubular members, for example toprevent egress of the embolic from a cavity. The device can be detachedto provide a permanent seal of the orifice, and can retain the embolicwithin the cavity. The device may be used in conjunction with a stent orother retention device to assist the sealing element in maintaining theseal.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a side view of an occlusive device of the present inventionin the extended or nondeployed conformation.

FIG. 2. is a side view of the device of FIG. 1 in the collapsed ordeployed position.

FIG. 3 is a perspective view of the device of FIG. 2 in the collapsedposition, demonstrating a disk-like shape suitable for occluding anorifice or aneurysm.

FIG. 4 is a perspective view of one locking mechanism which can beincorporated into the occlusive device to lock it in the deployed shape.

FIGS. 5 and 6 are side views of this locking mechanism in unlocked andlocked positions, respectively.

FIG. 7 shows a deployed occlusive device positioned within an aneurysm.

FIGS. 8-10 show an occlusive device in use in occluding an aneurysm. Anoptional contrast agent is shown within the sealing element of thedevice. The contrast agent is introduced into the sealing element,causing it to swell and aiding in its visualization. As an embolic isintroduced through the device to occlude the aneurysm, the sealingelement is compressed, causing the contrast agent to be forced out. Thisallows the introduction of a non-radioopaque embolic to be monitored.

FIGS. 11 and 12 show a magnified side view of the distal end of thesecond or inner tubular member of the device. An electrolyticallydetachable link is shown, positioned so that the distal end of themember may be detached. This allows the use of quick-setting liquidembolics which could otherwise harden while still within the end of theinner tubular member and hinder detachment.

FIGS. 13-17 present views of different valves which may be incorporatedinto the second tubular member to prevent egress or backflow of anembolic through the device after deployment.

FIGS. 18-19 show a multiport tip which may be incorporated on the distalend of the second tubular member to allow for slow release of a liquidembolic onto the sealing element prior to delivery of the bulk of theembolic into the interior of the cavity to be occluded.

FIGS. 20-22 show a variation of the device in which the first tubularmember acts as a sheath for the sealing element during deployment. Thefirst tubular member can then be retracted over the sealing element,releasing a catch on the second end of the sealing element. A distal endof the first tubular member can then engage the catch and collapse orcinch the sealing element into the deployed shape.

FIG. 23 shows a schematic side view of an occlusive device comprising atethering element designed to protrude into a cavity and engage anembolic inserted therein to lock the embolic and device together.

DETAILED DESCRIPTION OF THE INVENTION

Before the present invention is described in detail, it is to beunderstood that this invention is not limited to the particularmethodology, devices or apparatuses described, as such methods, devicesor apparatuses can, of course, vary. It is also to be understood thatthe terminology used herein is for the purpose of describing particularembodiments only, and is not intended to limit the scope of the presentinvention.

Use of the singular forms “a,” “an,” and “the” include plural referencesunless the context clearly dictates otherwise. Thus, for example,reference to “an embolic” includes a plurality of embolics, reference to“a locking mechanism” includes a plurality of such mechanisms, and thelike.

Terms such as “connected,” “attached,” “linked,” and “conjugated” areused interchangeably herein and encompass direct as well as indirectconnection, attachment, linkage or conjugation unless the contextclearly dictates otherwise.

Unless defined otherwise or the context clearly dictates otherwise, alltechnical and scientific terms used herein have the same meaning ascommonly understood by one of ordinary skill in the art to which thisinvention belongs. Although any methods and materials similar orequivalent to those described herein can be used in the practice ortesting of the invention, the preferred methods and materials are nowdescribed.

All publications mentioned herein are hereby incorporated by referencefor the purpose of disclosing and describing the particular materialsand methodologies for which the reference was cited. The publicationsdiscussed herein are provided solely for their disclosure prior to thefiling date of the present application. Nothing herein is to beconstrued as an admission that the invention is not entitled to antedatesuch disclosure by virtue of prior invention.

“Optional” or “optionally” means that the subsequently described eventor circumstance may or may not occur, and that the description includesinstances where the event or circumstance occurs and instances in whichit does not.

Methods and devices for blocking orifices and occluding cavities withina patient are provided. An occlusion device 100 comprises first andsecond tubular members 110, 120 attached at their distal ends 112, 122to a collapsible sealing element 130. See FIGS. 1-3 and 20-22. Movementof the tubular members relative to one another allows the manipulationof the sealing element to block an orifice.

The tubular members are generally elongate and flexible, to permit theirmanipulation throughout the body of a patient. Typically the device willbe introduced through the vasculature, for example through a leg vein,to treat an aneurysm within a blood vessel. The tubular members havecentral lumens 114, 124 extending longitudinally therethrough, with thesecond tubular member 120 located within the lumen 114 of the firsttubular member 110. The tubular members are generally axially aligned,and may be coaxial. The second tubular member may substantially occupythe lumen of the first tubular member, or a space may be providedbetween the tubular members, permitting introduction of a fluid (forexample a contrast agent) into the interior of the sealing element 130.Alternatively a catheter may be used to introduce a fluid into thesealing element, where desired, or one or more ports fluidly connectedto the interior of the sealing element may be incorporated into thedevice.

The second tubular member communicates with the interior of theaneurysm, and its lumen can be used for positioning on a guidewire andintroducing embolics into an aneurysm or other cavity. In somevariations, the second tubular member may be detached prior tointroduction of all or some of the embolics, allowing for introductionof larger embolic devices which can be received within the larger lumenof the first tubular member once the second tubular member is removed.Where the second tubular member is detached first and removed, the firsttubular member then communicates with the interior of the aneurysm.

The tubular members can be made of any suitable flexible material whichcan function in the device as described, and may be a composite ofmaterials. Polymeric materials, including copolymeric materials, can beused, for example polytetrafluoroethylene (PTFE), polyether-blockco-polyamide copolymers (e.g., PEBAX®), or urethane. Flexible metals canalso be used, for example wires such as stainless steel wire, nitinol,etc. Materials can be incorporated to improve kink resistance.Hydrophilic coatings can be added to improve bioacceptability. In oneexample, a tubular member can comprise an inner layer of PTFE, astainless steel wire winding, a polymeric layer, and a dip coating of ahydrophilic agent. The tubular members may incorporate visualization orcontrast agents; for example, the second tubular member 120 mayincorporate a contrast agent 123 allowing determination of the positionof the tip during introduction.

The first and second tubular members can be manually positionedindividually, or can be connected to a device capable of controllingtheir movements. The tubular members can incorporate hubs at a proximalend for attachment to such a device. A handle may be included to lockthe outer and inner tubular members and thereby prevent the prematuredeployment of the device during delivery.

The second lumen 124 may be disposed around a guidewire 180 used toguide the introduction of the device into a desired cavity or orifice,or the device may be used without a guidewire. See FIGS. 1-2. Desirably,a radioopaque material may be incorporated into the guidewire, one orboth of the tubular members, or all three, to permit visualization oftheir positions during use.

Unlike other devices, the detachable sealing element described hereinrequires no unique guidewire that must be specially manufactured, butallows the use of unmodified commercially available guidewires, therebydecreasing costs and simplifying manufacture and operation. The deviceof the present invention requires no physical attachment to theguidewire, and so can in principle be used with any guidewire ofsuitable dimensions.

The device advantageously displays a low profile, simplifyingintroduction of the device and permitting introduction into more remoteareas of, for example, the vasculature, then could be reached by athicker device.

The sealing element is detachably connected at its first and second ends132, 134 respectively to the first and second tubular members at theirdistal ends, allowing the sealing element to remain implanted within theorifice once detached. By distal end is meant a position at or near thedistal end of a tubular member, and does not preclude the tubular memberfrom extending distally past the point to which the sealing element isattached, such that portions of the tubular members may be included inthat part of the device which is detached. In one variation, anextension of the second tubular member beyond the sealing element isincluded to permit more advanced introduction of an embolic 170 past thesealing element. In another variation, the sealing element includes acatch or lever system 137 at its first end for engagement of the firstdistal end 112 of the first tubular member by abutment, and is nototherwise connected to the first tubular member. Extension of the firsttubular member relative to the second tubular member when this abutmentsystem is engaged causes the cinching or collapse of the sealing elementinto the deployed shape. See FIGS. 20-22.

The detachable connections 140, 140 a to the first and second tubularmembers may be of the same type, or may be different. Any form ofconnection that allows for implantation of the device and that can bedetached upon deployment of the sealing element can be used. Theconnection may be an adhesive connection, a friction fit, a ring andjoining rib, a mechanically detachable joint, or an electrolyticallydetachable joint. Desirably, at least one of the detachable connectionsis an electrolytic joint constructed of a material that is susceptibleto electrolytic dissolution in blood and that dissolves in response toan intentionally timed and applied electrolytic signal. An example ofdetachment of the second tubular member 120 is shown in FIGS. 11-12. Thelumen 124 and the second tubular member can be formed so that the distalend 122 will cleanly separate upon activation of electrolyticallydetachable connection 140 a.

The sealing element 130 can be made of any material suitable for thedesired application. The sealing element can be formed of abio-compatible fabric-like material, such as a braided, woven polymericmaterial, or a nonwoven polymeric material such as an electrostaticallyspun membrane for example as described in U.S. Pat. No. 6,156,064 issuedDec. 5, 2000 to Choinard, and Medical Textile Structures: An Overview byBhupender S. Gupta (Medical Plastics and Biomaterials, January 1998;http://www.devicelink.com/mpb/archive/98/01/001.html). Whether in afabric-like form or not, the sealing element may comprise one or morepolymers, for example polyethylene, polypropylene, polyvinylchloride, apolyamide (e.g., Nylon), polyurethanes, polyvinylpyrrolidone, polyvinylalchohols, polyvinylacetate, cellulose acetate, polystyrene,polytetrafluoroethylene, a polyester (e.g. polyethylene terphthalate(Dacron)), polyurethane, silk, and cotton. The sealing element cancomprise one or more biodegradable or bioabsorbable materials, forexample polylactic acid, polyglycolic acid, or a copolymer thereof(Other elements of the device, embolics and/or stents may comprise suchmaterials as well.) A radio-opaque material 135 can be woven orotherwise incorporated into the sealing element (i.e., tantulumplatinum, gold, etc.) to facilitate and assist in guidance through avascular system utilizing radiography or fluoroscopy. FIG. 3 shows aperspective view of an occlusive device in the collapsed or deployedshape, with the generally disklike sealing element extending generallyradially outwards. Radioopaque fiber 135 is shown woven into the sealingelement.

The sealing element can comprise an elastomer, allowing it to be filledwith a liquid (e.g. a contrast agent 136) and can expand, and can thenbe contracted upon introduction of an embolic 170 into the cavity andthereby aid in monitoring of the process. See FIGS. 8-10. Furthermore,the sealing element can comprise or be made entirely of a metallic wire,for example platinum wire or stainless steel wire, which can itself beradioopaque. The sealing element may be formed of a material (e.g.,nitinol) capable of assuming a shape memory and may have a predetermineddeployed shape. The sealing element may be porous or nonporous. Whereporous, the mesh may be preclotted prior to insertion into the cavityusing clotting factors which may optionally be obtained from the patientbeing treated. The sealing element may take the form of a braided tubecomprising multiple different materials, which can impart differentproperties, e.g. polymer yarns, metal wires, radioopaque strands, etc.

The sealing element 130 may assume any generally flattened shape whencollapsed.

The inherent shape of the collapsed sealing element can be controlled inany of various ways, for example by using combination(s) of differentmaterials to form the element, or by using combinations of materials ofdifferent thickness. Typically the sealing element will assume agenerally disklike shape in the collapsed shape, which is generallycollapsed longitudinally along the axis of the second, or both, tubularmembers, and extends generally radially outwards therefrom. The tubularmember may include one or more folds and/or grooves to cause the sealingelement to fold at a predetermined location when collapsed.

The tubular members are disposed so as to retain the sealing element inan extended shape generally extended longitudinally along the axis ofthe second, or both, tubular members during introduction of the device,and can be moved relative to one another, typically sliding along oneanother coaxially to expand and contract the sealing element. In somevariations, the sealing element may be so maneuvered using the tubularmembers a number of times during introduction in order to obtain adesirable position. This control scheme in those variations allows forthe reversible manipulation of the sealing element while being deployed.

The sealing element can be protected by a retractable sheath 160 thatcan cover the sealing element during introduction of the device. Thesheath can then be retracted in the vicinity of the passage or orifice,exposing the sealing element and allowing its use as a seal. The sheathitself may be used to position the sealing element in certainvariations, and the outer tubular member may act as the sheath. As shownin FIGS. 20-22, the sheath 160 (also serving as first outer tubularmember 110) protects the sealing element 130 during positioning. Thesheath 160 can then be retracted to release the sealing element andcatches or levers 137 on the second end of the sealing element. Thedistal end of the sheath 160 is shaped so that it can engage the catchsystem 137 and thereby by used to push the second end of the sealingelement, comprising locking elements 150 a in the variation shown inFIGS. 20-22, into the deployed shape. The sheath 160 can be furtherpushed to engage the locking system 150, 150 a. (Alternatively, theposition of the sheath can be maintained in one place engaging thelevers while the inner tubular member is pulled or retracted, or bothtubular members may be moved.)

The device may incorporate a multiport tip with ports 125 at its distalend 122 for deploying an embolic 170 distal to the device to preventefflux through the sealing element 130. See FIGS. 18-19. Where thesealing element is a porous material such as mesh, using such amultiport tip, the operator can first introduce a small amount of theembolic to contact the mesh and allow it to harden prior to introductionof a sufficient amount of embolic. A catheter may alternatively be usedto introduce a liquid embolic or other agent into the cavity, and maypass through the second lumen 124. The second lumen 124 itself may alsobe used to deliver the embolic.

Any embolic 170 suitable for occluding a cavity can be used. Exemplaryembolics which can be used include hardening agents, coils (e.g. “liquidcoils”) which may be delivered over a guidewire passing through thedevice, fibers, particles, supporting members or microspheres, orcombinations thereof. The embolic material, as ultimately deployed, mustbe capable of retention within the cavity by the sealing element beingused. The device may comprise a tethering element or elements 172 (FIG.23) that anchors the embolic to the sealing element, which may extendfrom the tubular member(s), their lumen(s), and/or the sealing element.The anchoring may take place through any available mechanism, forexample through physical entanglement (e.g., where the embolic comprisescoils), through entrapment of the element within a hardening embolic, byentrapment within the embolus, or by combinations of mechanisms. In onevariation, additional loops of material (e.g. wire, fiber or yarn) mayextend from the sealing element towards the distal end of the innertubular member, which loops will protrude into the cavity upon cinchingof the sealing element and be available for entanglement with theembolic. Diffusing tips may be used on the end of the catheter or portused to introduce the embolic and thereby allow the embolic to bedeployed evenly.

The device may incorporate one or more locking elements 150, 150 atending to fix the sealing element in the deployed shape uponengagement. See, for example, FIGS. 4-6. Any locking mechanism that canlock the sealing element into the deployed shape can be used. Exemplarylocking mechanisms suitable for use in the occlusive device includelatching systems, dimples, detents including rim and bump-ring systems,friction-fit elements, entanglement systems, and locking barbs (FIGS.4-6). Entanglement systems can include, for example, hook-and-loopsystems for example VELCRO® fasteners), and systems in which a slidablemember such as a tube or post passes into a mesh or braid (e.g., nitinolbraid) which seals behind the end of the slidable member and preventsits removal. Mechanical expansion elements can be incorporated aslocking elements, wherein movement of the tubular members releases anexpandable element (for example, a ring or strips) once the tubularmembers exceed a particular relative offset which prevents return to theextended shape. Engagement of the locking mechanism causes the sealingelement to at least strongly resist movement away from the collapsedshape, and may effectively permanently lock the sealing element in thatposition.

Where the locking mechanism is located on the tubular members, typicallythe locking elements 150, 150 a are located on or near the distal ends112, 122 of the tubular members, but in principle can be locatedanywhere on the tubular members that allow them to be locked in aposition fixing the sealing element in the deployed shape.

Alternatively or additionally, the locking mechanism 150 can be locatedwithin the sealing element 130 itself. For example, hook-and-loopmembers can be located within the sealing element so that, when thesealing element is moved into the deployed shape, the inner surface ofthe sealing element, brought into opposition by the movement of thefirst and second tubular members, is locked into the deployed shape byvirtue of attachment of the hooks and loops brought into opposition.Locking mechanisms may be located on the tubular members, on the sealingelement, or on the tubular members and the sealing element.

The device may include one or more valves 128 or valve-like elementscontrolling the passage of fluid through the lumen(s) of the tubularmembers. See FIGS. 13-17. These valves can be used to prevent egress ofan embolic 170 from an aneurysm 190 after occlusion. Any elementsuitable for sealing the lumen(s) can be employed as a valve. The valvesmay take the form of flaps (FIGS. 16-17) that are released inconjunction with detachment of the device, or may take the form of anannular seal (FIGS. 13-15) which is similarly released on detachment ofthe device to seal the lumen. The valves 128 need not only deploy inconjunction with detachment of the device, and their deployment may beseparately controllable.

The device may be provided sealed in a package in single use form, andmay be provided sterilized for performing a medical procedure using anysuitable sterilizing technique, for example using heat, ultravioletlight, radiation, and/or a sterilizing gas (e.g., ethylene oxide). Thedevice may be packaged with a guidewire suitable for use in introducingthe device into an orifice or body cavity.

The devices described herein can, in principle, be used for blocking anyorifice or for occluding any cavity within the body, limited only byaccessibility to the device and by the shape and size of the orifice orcavity. The device may be used to seal an atrial septal defect, or toseal a penetrating wound. The device may be used as a temporary orpermanent seal.

Most typically, the device will be used to seal an aneurysm 190 (FIG.7), and may be employed with an embolic as described above. The sealingelement 130 is positioned within the aneurysm 190 so that it occludesthe neck 191. An embolic may then be introduced and the device detachedin place. In some variations, the device may be removed after theembolic has hardened or otherwise will maintain an occlusion of theaneurysm or other cavity in the absence of the sealing element 130. Aretention device (stent or similar device) may optionally be employed toassist in maintaining the occlusion of the cavity.

Although the invention has been described in some detail with referenceto the preferred embodiments, those of skill in the art will realize, inlight of the teachings herein, that certain changes and modificationscan be made without departing from the spirit and scope of theinvention. Accordingly, the invention is limited only by the claims.

What is claimed is:
 1. An occlusive device, comprising: a first tubularmember comprising a first distal end and a first lumen; a second tubularmember comprising a second distal end and a second lumen, said secondtubular member received within the first lumen of the first tubularmember; a collapsible sealing element adapted to be disposed within abody cavity across a passage thereto, said sealing element having acollapsed shape and an extended shape, said sealing element comprising afirst end and a second end, said first end detachably connected to saidfirst tubular member at or near said first distal end, and said secondend detachably connected to said second tubular member at or near saidsecond distal end, said extended shape being generally extendedlongitudinally along the axis of the second tubular member, saidcollapsed shape being generally collapsed longitudinally along said axisand expanded generally radially outwards therefrom to form a barrier;said first and second tubular members being longitudinally movablerelative to one another to control the movement of the sealing elementbetween the collapsed and extended shapes; and a valve which seals thesecond lumen to prevent egress of an embolic therethrough.
 2. Theocclusive device of claim 1, further comprising a locking mechanismseparate from the collapsible sealing element that can be engaged tolock the sealing element in the collapsed shape.
 3. The occlusive deviceof claim 2, wherein the locking mechanism is selected from the groupconsisting of a friction fit, a latch, an entanglement system, a dimple,a detent, and a locking barb.
 4. The occlusive device of claim 1,wherein the sealing element is provided with a protective sheath thatcan be retracted to release the sealing element.
 5. The occlusive deviceof claim 1, wherein the valve comprises flaps which are collapsed intothe second lumen after introduction of the embolic.
 6. The occlusivedevice of claim 1, wherein the valve comprises an annular collapsibleseal that collapses to seal the second lumen after detachment from thesecond tubular member.
 7. The occlusive device of claim 1, furthercomprising a plurality of ports near said second distal end forintroducing the embolic.
 8. A method of blocking an orifice within apatient, comprising introducing the device of claim 1 into the patient;positioning the sealing element to engage the orifice; manipulating thefirst and second tubular members to move the sealing element into thecollapsed shaped blocking said orifice; and detaching the sealingelement.
 9. An occlusive device, comprising: a first tubular membercomprising a first distal end and a first lumen; a second tubular membercomprising a second distal end and a second lumen, said second tubularmember received within the first lumen of the first tubular member; anda collapsible sealing element adapted to be disposed within a bodycavity across a passage thereto, said sealing element having a collapsedshape and an extended shape, said extended shape being generallyextended longitudinally along the axis of the second tubular member,said collapsed shape being generally collapsed longitudinally along saidaxis and expanded generally radially outwards therefrom to form abarrier, said sealing element positioned so as to be retained within thefirst tubular member during delivery of the device, said sealing elementcomprising a first end and a second end, said first end comprising adeployable engagement system for engaging the first distal end uponretraction of the first tubular member to expose the sealing element anddeploy the engagement system, and said second end detachably connectedto said second tubular member at or near said second distal end; saidfirst and second tubular members longitudinally movable relative to oneanother to control the movement of the sealing element between theextended and collapsed shapes.
 10. The occlusive device of claim 9,wherein the sealing element comprises a braided mesh tube.
 11. Theocclusive device of claim 10, wherein the mesh is selected from thegroup consisting of a polymer yarn, a polyester yarn, and a metal wire.12. The occlusive device of claim 11, wherein the metal wire is anitinol wire.
 13. The occlusive device of claim 10, wherein the meshcomprises a radioopaque element.
 14. The occlusive device of claim 10,wherein the mesh comprises a combination of different materials.
 15. Theocclusive device of claim 9, further including a guidewire slidablydisposed within the second lumen.
 16. The occlusive device of claim 9,further including an embolic material configured to occlude the bodycavity, wherein the embolic material is introducible into the bodycavity through the second lumen.
 17. The occlusive device of claim 9,wherein the first distal end is configured to abut the first end of thesealing element following exposure of the sealing element to move thesealing element from the extended shape to the collapsed shape.
 18. Theocclusive device of claim 9, wherein during delivery of the device, thefirst distal end abuts a proximally-facing surface of the second end ofthe sealing element.